Project Summary/Abstract: Pancreatic adenocarcinoma (PaC) is the fourth-leading cause of cancer death in the US, with 132,180 estimated new cases for 2005 and almost as many deaths. This high mortality rate is due to the fact that PaC is generally detected at an advanced stage, and there is no screening test available. Detection of clinical disease at an earlier stage would effectively impact on patient survival enabling more patients to benefit from surgical resection. Our goal is to identify PaC specific biomarkers, and to develop and commercialize new, sensitive, specific, non-invasive immunodiagnostic assays based on patient serum for PaC detection. These assays would improve diagnosis, and disease management. In this SBIR Phase I project, we propose to apply proprietary technologies to identify biomarkers for the early detection of PaC. Our innovative antibody-based approach involves: i) a collection of polyclonal antibodies raised against known and unknown human proteins; ii) a proprietary protein array allowing multiplex analysis of a large number of clinical samples using a large number of antibodies; and iii) a large collection of clinical specimens. Phase I research will focus on the comparative analysis of serum protein expression profiles between PaC patients, benign and normal controls, using a large number of antibodies from our collection. Statistical analysis of the data points generated in this study, will enable us to select candidate biomarkers that discriminate PaC from normal and benign conditions. Selected biomarkers will be further validated in Phase II, thus leading to the development of an immunodiagnostic assay for PaC detection. Project Narrative: Pancreatic cancer is the fourth-leading cause of cancer death in the US, and has the shortest life expectancy of all malignancies when discovered. It is generally detected at an advanced stage, when cancer cannot be treated by surgery alone. The development of a simple immunodiagnostic assay based on patient serum to detect pancreatic cancer would have a profound impact on patient survival and reduce mortality from this disease. [unreadable] [unreadable] [unreadable]